Axsome enrolls first patient in COAST-1 study

Axsome Therapeutics has enrolled the first patient in its COAST-1 study. | Courtesy of Shutterstock

Axsome Therapeutics Inc., a clinical-stage biopharmaceutical company that creates novel therapies to manage central nervous system disorders, has enrolled the first patient in its phase-three COAST-1 trial.

The goal of the Clinical Knee Osteoarthritis (OA) Symptoms Treatment 1 study is to determine the effectiveness and safety of the company’s new AXS-02 treatment. The goal is to eliminate the pain that comes with knee osteoarthritis. The pain is from the patients’ bone marrow lesions (BMLs).

AXS-02, a potent osteoclast inhibitor, is created to be a targeted, oral, potentially first-in-class, non-opioid therapeutic to address patients’ chronic pain.

“BMLs, which are visible on MRI, are linked to knee pain and cartilage damage, and are present in a significant percentage of patients with knee OA,” Graeme Jones, head of the musculoskeletal unit at the Menzies Research Institute and head of Royal Hobart Hospital's department of rheumatology, said. “Unfortunately, there is currently no drug approved to treat knee OA pain associated with BMLs. This trial is important because it explores a potential treatment for this unmet need and because it is the first knee OA trial for regulatory approval to use BMLs for patient selection.”

If the drug is approved and effective, it could bring relief to countless patients around the world.

“Knee OA is a significant source of chronic disability for millions of patients,” Thomas Schnitzer, professor at Northwestern University Feinberg School of Medicine, said. “These processes can lead to loss of normal joint function and may progress to eventual joint failure resulting from progressive cartilage loss. The condition substantially decreases day-to-day functioning and quality of life and may necessitate surgical replacement of the knee joint.”